(60 days)
The Panorama MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips Panorama Enhancements, structured according to your request.
Please note: This document describes a submission for a Magnetic Resonance Imaging (MRI) System, specifically "Panorama Enhancements". The information provided is primarily focused on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study establishing new diagnostic performance metrics for an AI algorithm. Therefore, many of your requested points related to AI performance, ground truth, and expert evaluation are not applicable or extractable from this type of documentation.
Acceptance Criteria and Study for Philips Panorama Enhancements
This submission focuses on demonstrating substantial equivalence of the "Panorama Enhancements" to previously cleared MRI systems (Philips Panorama 0.6T/0.23T and Philips Intera family). The acceptance criteria for this type of submission are primarily related to meeting performance standards and maintaining safety and effectiveness comparable to the predicate devices. The "study" described is essentially a comparison table (Substantial Equivalence Chart) demonstrating how the new enhancements align with or are within the acceptable ranges of the predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for an MRI system enhancement, the "acceptance criteria" are implied to be the specifications and performance characteristics of the predicate devices, and the "reported device performance" is how the new "Panorama Enhancements" compare to these predicates.
| Parameter | Acceptance Criteria (Predicate Devices - K013858, K974844, K001796) | Reported Device Performance (Panorama Enhancements - 0.6T MR Imaging System) | Reported Device Performance (Panorama Enhancements - 0.23T MR Imaging System) |
|---|---|---|---|
| Gradient Coils | Water-cooled self-shielded gradient system (K013858, K974844) | Same (Water-cooled self-shielded gradient system) | Same (Water-cooled self-shielded gradient system) |
| Max. Gradient Strength (0.6T) | 20 mT/m (K013858) | 23 mT/m | N/A |
| Max. Gradient Strength (0.23T) | 16 mT/m (x,y direction), 18 mT/m (z direction) (K974844) | N/A | 21 mT/m |
| Max. Slew Rate (0.6T) | 40 T/m/s (K013858) | 75 T/m/s | N/A |
| Max. Slew Rate (0.23T) | 25 T/m/s (x,y direction), 40 T/m/s (z direction) (K974844) | N/A | 50 T/m/s |
| RF amplifiers | Max power 9 kW (K013858) for 0.6T; 5 kW solid state (K013858) for 0.23T | Same (Max power 9 kW) | Same (5 kW solid state) |
| RF transmitter coils | Upper and lower, planar coils, integrated in magnet, water cooling. Tuning adjusted to 0.6T/0.23T field strength (K013858) | Same | Same |
| Receive only RF coils | Head, Head and Neck, Neck, Extremity, Body and Spine, Multipurpose, TMJ, Breast, Shoulder (K013858, K974844, K002539, K981959, K013528, K983143) | Same and Synergy Head and Neck | Same and Synergy Body |
| Magnet Façade | Fiberglass enclosure (K013858, K974844) | New design, cover backdoor of ABS, otherwise material the same. | New design, cover backdoor of ABS, otherwise material the same. |
| Base Software | Windows 2000 based Graphical User Interface and scan / reconstruction software with multi-tasking capability (K013858) | Same | Same |
| MRGP software | Interventional MRI capabilities (K013858) | Same | Same |
| Imaging sequences | Field Echo, Spin Echo, Dual Echo, Dual Spin Echo, Inversion Recovery, Dual Inversion Recovery, Fast Spin Echo, EXPRESS, CBASS, MRCP, MRA, STIR, FLAIR, TSHIRT, RF-FAST, CE-FAST, DWISE (K013858) | Same | Same |
| Acquisition and reconstruction techniques | Presaturation, MAST, ODA, PCS, no phase wrap-around, no slice wrap around, dynamic imaging, cardiac gating, optimized bandwidth, turbo multislice, MAO, chemical fat saturation, phase conjugate symmetry, read conjugate symmetry, true res, true slice, elliptic encoding, RAM, CODA, MTC, dynamic examination curve, contrast dynamic imaging, reconstruction filters, respiratory gating, multiplanar reconstruction, maximum intensity projection, phase correction, fat/water suppression, ADC map. SENSE capability. SyncraScan (K013858, K001796) | Same | Same |
| User Interface | Layout, see Figure 2a (K013858) | Layout change, see Figure 2b. | Layout change, see Figure 2b. |
| Normal Operating Mode (Time Varying) | According to IEC 60601-2-33 FDIS script 2001-11-02, default (K013858) for 0.6T; ≤ 40 T/s (K974844) for 0.23T | ≤ 35.4 T/s (IEC60601-2-33, second edition, directly determined) | ≤ 35.4 T/s (IEC60601-2-33, second edition, directly determined) |
| First Level Controlled Operating Mode (Time Varying) | According to IEC 60601-2-33 FDIS script 2001-11-02, default (K013858) for 0.6T; ≤ 60 T/s (K974844) for 0.23T | ≤ 44.3 T/s (IEC60601-2-33, second edition, directly determined) | ≤ 44.3 T/s (IEC60601-2-33, second edition, directly determined) |
| Normal Operating Mode (Radiofrequency Absorption) | Limited to a maximum level of 1.2 W/kg (K013858, K974844) | Same | Same |
| First Level Controlled Operating Mode (Radiofrequency Absorption) | Limited to a maximum value of 3.2 W/kg (K013858, K974844) | Same | Same |
| Acoustic Noise (Typical) | 87 dBA (average) 102 dBA (peak) (K013858) for 0.6T; A-weighted average value |
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.